JP4940332B2 - catheter - Google Patents

Description

  The present invention relates to a catheter. More specifically, the present invention relates to a catheter capable of easily changing the direction of the vicinity of the distal end inserted into the body cavity by operating the operation portion on the proximal end side arranged outside the body. .

  In a catheter such as an electrode catheter inserted through a blood vessel and into the heart, the orientation of the distal end (tip) of the catheter inserted into the body is the proximal end (proximal end or proximal side) of the catheter placed outside the body. It is deflected by operating the operation unit mounted on the. In order to smoothly insert the catheter into a desired site such as the inside of the heart, the vicinity of the distal end of the catheter is required to be bendable with a predetermined curve shape.

  In a so-called multi-lumen catheter in which a plurality of lumens are formed along the axial direction, an operation wire is conventionally inserted into the lumen formed at a position shifted from the central axis of the catheter. Then, by pulling the operation wire in the operation part, the direction of the distal end is deflected by curving the vicinity of the distal end of the catheter in the eccentric direction of the lumen, that is, the side displaced from the central axis of the tubular member (See Patent Document 1).

JP 2000-288095 A

  In conventional catheters, when the distal side of the catheter is bent by pulling the pull wire, the curvature radius of the curved portion of the catheter is uniform, making it difficult to cope with more advanced catheter technology. . For example, as a heart treatment or examination using a catheter, the catheter is inserted through the femoral vein, approached from the inferior vena cava to the coronary sinus, and the tip of the catheter curved along the inner wall of the coronary sinus reaches the right atrium The technology to make it known is known. In such a catheter technique, if the radius of curvature is uniform when the distal end of the catheter is curved, there is a problem that the catheter insertion operation becomes difficult.

  This invention is made | formed in view of such a subject, The objective is to provide the technique which can improve the operativity of a catheter according to a more advanced catheter technique.

One embodiment of the present invention is a catheter. The catheter is inserted through a flexible tubular member having a plurality of lumens formed along the axial direction, and an operating lumen out of the central axis of the tubular member among the plurality of lumens. An operation wire connected in the vicinity of the distal end of the tubular member, and a hollow portion having an inner diameter smaller than the inner diameter of the operation lumen is provided between the distal end and the proximal end of the tubular member. And when the operation wire is linear, the control member is provided at a predetermined position on the distal side of the control member, and the outer diameter is smaller than the inner diameter of the hollow portion. A large detent portion, and when the manipulation wire is pulled, a region distal to the detent portion of the manipulation wire is restrained by a region distal to the restraining member. .

  According to this aspect, when the manipulation wire is pulled, the detent member functions as an anchor that fixes a position at a predetermined distance from the distal end of the manipulation wire, whereby the radius of curvature of the curved catheter is reduced. Different from the restraining member on the distal side and the proximal side. Specifically, the radius of curvature of the catheter 2 proximal to the restraining member is smaller than the radius of curvature of the catheter distal to the restraining member. Thereby, the operativity of a catheter improves and the catheter technique which penetrates the front-end | tip part of a catheter to a more complicated path | route can be performed easily.

  In the catheter of the above aspect, when the detent portion is restrained by the restraining member, the radius of curvature of the tubular member distal to the detent portion may be larger than the curvature radius of the tubular member proximal to the detent portion. Good.

When the restraining members are provided at a plurality of locations between the distal end and the proximal end of the tubular member, and the operation wire is straightened, the plurality of detent portions are distal to the corresponding restraining members, respectively. You may provide in the predetermined location of the operation wire located in the side.

  According to the present invention, there is provided a technique capable of improving the operability of a catheter according to a more advanced catheter technique.

1A and 1B are a side view and a top view of the catheter according to Embodiment 1, respectively. It is sectional drawing on the AA line of FIG. 1 (A) and FIG. 1 (B) in the catheter which concerns on Embodiment 1. FIG. It is sectional drawing on the BB line of FIG. 1 (A) in the catheter which concerns on Embodiment 1. FIG. It is sectional drawing on the CC line of the catheter which concerns on Embodiment 1 in FIG.1 (B). 3 is a cross-sectional perspective view of the vicinity of a restraining member of the catheter according to Embodiment 1. FIG. It is sectional drawing which shows the shape of the front-end | tip part of a catheter when pulling operation wire for operation. It is sectional drawing which shows the shape of the front-end | tip part of a catheter when pulling operation wire for operation. 6 is a cross-sectional view of a catheter according to Embodiment 2. FIG.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate.

(Embodiment 1)
The catheter according to Embodiment 1 is an electrode catheter capable of tip deflection operation, for example, diagnosis or treatment of arrhythmia in the heart, in particular, the approach from the inferior vena cava to the coronary sinus, along the inner wall of the coronary sinus It is suitably used in a technique for causing the tip of a curved catheter to reach the right atrium.

  1A and 1B are a side view and a top view of the catheter according to Embodiment 1, respectively. As shown in FIGS. 1 (A) and 1 (B), the catheter 2 according to Embodiment 1 has a tip electrode 10 and ring-shaped electrodes 12a and 12b at the distal end of the tubular member 4. The tip electrode 10 and the ring-shaped electrodes 12a and 12b are fixed to the tubular member 4 using, for example, an adhesive.

  An operation handle 6 is attached to the proximal end of the tubular member 4. From the handle 6, lead wires of lead wires electrically connected to the tip electrode 10 and the ring electrodes 12a and 12b are drawn out. The handle 6 is equipped with a knob 7 for performing a deflection movement operation (swing operation) of the distal end portion of the tubular member 4.

  As will be described later, the tubular member 4 has a hollow structure having a plurality of lumens formed along the axial direction. The distal end portion of the tubular member 4 is relatively flexible and the proximal end portion of the tubular member 4 is relatively rigid.

  As will be described later, the tubular member 4 includes an inner cylinder member 4a and an outer cylinder member 4b. Further, as shown in FIGS. 1A and 1B, the outer cylinder member 4b is configured by being divided into an outer cylinder member 4b1, an outer cylinder member 4b2, and an outer cylinder member 4b3 in order from the distal side. . The outer cylinder member 4b1, the outer cylinder member 4b2, and the outer cylinder member 4b3 have higher flexibility in this order. For example, the ranges of Shore D hardness of the outer cylinder member 4b1, the outer cylinder member 4b2, and the outer cylinder member 4b3 are 30 to 63, 45 to 70, and 55 to 82, respectively.

  The main part of the tubular member 4 is made of a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane. The outer diameter of the tubular member 4 is generally about 0.6 to 3 mm. As will be described later, the lumen formed in the axial direction of the tubular member 4 has conductors connected to the tip electrode 10 and the ring-shaped electrodes 12a and 12b shown in FIGS. 1A and 1B, respectively. Threaded in an insulated state.

  The tip electrode 10 and the plurality of ring-shaped electrodes 12a and 12b are made of a metal having good thermal conductivity, such as aluminum, copper, stainless steel, gold, or platinum. In order to provide a good contrast property for X-rays, the tip electrode 10 and the ring electrodes 12a and 12b are preferably made of platinum or the like. The outer diameter of the tip electrode 10 and the ring-shaped electrodes 12a and 12b is not particularly limited, but is preferably about the same as the outer diameter of the tubular member 4, and is usually about 0.5 to 3 mm.

  2 is a cross-sectional view of the catheter according to Embodiment 1 taken along the line AA in FIGS. 1 (A) and 1 (B). 3 is a cross-sectional view taken along line BB in FIG. 1A of the catheter according to the first embodiment, and FIG. 4 is a cross-sectional view taken along line CC in FIG. 1B of the catheter according to the first embodiment. is there. FIG. 5 is a cross-sectional perspective view of the vicinity of a restraining member of the catheter according to the first embodiment. In addition, the conducting wire 70 mentioned later in FIG. 5 is abbreviate | omitted.

  As shown in FIGS. 2, 3, and 4, the tubular member 4 includes an inner cylinder member 4a having a plurality of lumens and an outer cylinder member 4b that covers the inner cylinder member 4a. The first lumen 20, the second lumen 22, the third lumen 24 and the fourth lumen 26 are formed along the axial direction. The first lumen 20 is provided at a position facing the second lumen 22 across the central axis 21 of the tubular member 4. That is, the first lumen 20 is provided at a position shifted from the central axis 21 of the tubular member 4. The third lumen 24 is provided at a position facing the fourth lumen 26 across the central axis 21 of the tubular member 4. In the present embodiment, the line connecting the first lumen 20 and the second lumen 22 intersects with the line connecting the third lumen 24 and the fourth lumen 26. The diameters of the first lumen 20 and the second lumen 22 are about 0.1R to 0.45R, where R is the diameter of the tubular member 4. The diameters of the third lumen 24 and the fourth lumen 26 are approximately 0.1R to 0.45R, where R is the diameter of the tubular member 4.

  The first lumen 20 is an operation lumen, and an operation wire 40 is slidably inserted into the first lumen 20. An anchor 41 having a larger diameter than the operation wire 40 is formed at the distal end of the operation wire 40. The proximal end of the operation wire 40 is connected to a knob 7 shown in FIGS. 1 (A) and 1 (B).

  As shown in FIGS. 3 and 4, a recess 50 is formed inside the tip electrode 10. The recess 50 is filled with solder 60. The distal end of the operation wire 40 is embedded in the solder 50 and fixed to the solder 60 and the tip electrode 10, thereby being connected to the vicinity of the distal end of the tubular member 4. Further, as described above, the proximal end of the operation wire 40 is fixed to the knob 7 of the handle 6. Accordingly, by operating the knob 7 shown in FIGS. 1A and 1B, the operation wire 40 is pulled, and the distal end of the catheter 2 is necked in the direction of the arrow X in FIG. 1B. Swing deflection is possible. In the present embodiment, since the anchor 41 is provided at the distal end of the operation wire 40, the distal end of the operation wire 40 is difficult to come out of the solder 60. Thereby, the operation reliability of the catheter 2 can be improved.

  As shown in FIG. 3, a conducting wire 70 is inserted through the second lumen 22. The distal end of the conductor 70 is embedded in the solder 60. Thereby, the conducting wire 70 and the tip chip electrode 10 are electrically connected via the solder 60.

  Further, as shown in FIG. 4, a conducting wire 80 is inserted through the third lumen 24. The distal end of the conducting wire 80 is fixed to the ring-shaped electrode 12 a through an opening 13 a formed in the tubular member 4. The distal end of the conducting wire 80 is fixed to the ring-shaped electrode 12a using, for example, welding or soldering. Thereby, the conducting wire 80 and the ring-shaped electrode 12a are electrically connected.

  A conducting wire 82 is inserted through the fourth lumen 26. The distal end of the conducting wire 82 is fixed to the ring-shaped electrode 12 b through the opening 13 b formed in the tubular member 4. The distal end of the conducting wire 82 is fixed to the ring-shaped electrode 12b using, for example, welding or soldering. Thereby, the conducting wire 82 and the ring-shaped electrode 12b are electrically connected.

  The inner cylinder member 4a includes a relatively flexible member 4a1 disposed on the distal end side and a relatively inflexible member 4a2 disposed on the proximal end side. In this embodiment, the Shore D hardness of the member 4a1 is 30 to 63, and the Shore D hardness of the member 4a2 is 4a1 or more. The length of the inner cylinder member 4a is 20 to 300 mm, and the inner cylinder member 4a extends from the distal end of the tubular member 4 to a range of 15 to 280 mm.

  A restraining member 100 is provided as an intermediate member between the proximal end of the member 4a1 and the distal end of the member 4a2 (see FIG. 5). Examples of the material constituting the restraining member 100 include a liquid crystal polymer and stainless steel. The outer side of the restraining member 100 is covered with the outer cylinder member 4b2. The outer cylinder member 4b2 overlaps with a part of the proximal side of the member 4a1 and a part of the distal side of the member 4a2, and the outer cylinder member 4b2 is a part of the proximal side of the member 4a1 and a part of the member 4a2. It is bonded to a part of the rear side. Thereby, the improvement of the joining strength of the outer cylinder member 4b and the inner cylinder member 4a is achieved.

  In the restraining member 100, a hollow portion 102 having an inner diameter smaller than the inner diameter of the first lumen 20 is provided along the axial direction of the catheter 2, corresponding to the first lumen 20. Further, the inner diameter of the hollow portion 102 is larger than the outer diameter of the operation wire 40. The opening on the distal side of the hollow portion 102 faces the opening on the proximal side of the first lumen 20 provided in the inner cylinder member 4a1. The opening on the proximal side of the hollow portion 102 faces the opening on the distal side of the first lumen 20 provided in the inner cylinder member 4a2. As a result, the first lumen 20 provided in the inner cylinder member 4a1 and the first lumen 20 provided in the inner cylinder member 4a2 communicate with each other, and the aforementioned operation wire 40 is inserted into the hollow portion 102. Can do.

  Further, the restraining member 100 is provided with a hollow portion 104 having an inner diameter equivalent to the inner diameter of the second lumen 22 along the axial direction of the catheter 2, corresponding to the second lumen 22. The opening on the distal side of the hollow portion 104 faces the opening on the proximal side of the second lumen 22 provided in the inner cylinder member 4a1. Further, the opening on the proximal side of the hollow portion 104 is opposed to the opening on the distal side of the second lumen 22b provided in the inner cylindrical member 4a2. Accordingly, the second lumen 22 provided in the inner cylinder member 4a1 and the second lumen 22 provided in the inner cylinder member 4a2 communicate with each other, and the above-described conductive wire 80 can be inserted into the hollow portion 104. .

  Further, the restraining member 100 is provided with a hollow portion 106 and a hollow portion 108 along the axial direction of the catheter 2 corresponding to the third lumen 24 and the fourth lumen 26, respectively. The inner diameters of the hollow portion 106 and the hollow portion 108 are equal to the inner diameters of the third lumen 24 and the fourth lumen 26, respectively. The openings on the distal side of the hollow portion 106 and the hollow portion 108 are opposed to the openings on the proximal side of the third lumen 24 and the fourth lumen 26 provided in the inner cylinder member 4a1, respectively. Moreover, the opening of the proximal side of the hollow part 106 and the hollow part 108 has opposed the opening of the 3rd lumen 24 and the 4th lumen 26 which were provided in the inner cylinder member 4a2, respectively. The third lumen 24 provided in the inner cylinder member 4a1 and the third lumen 24 provided in the inner cylinder member 4a2 communicate with each other, and the fourth lumen 26 provided in the inner cylinder member 4a1 The fourth lumen 26 provided in the tubular member 4a2 communicates with the fourth member 26a. Thereby, the conducting wire 82 described above can be inserted into the hollow portion 106.

  The operation wire 40 inserted into the hollow portion 102 is provided with a detent portion 110 at a predetermined position distal to the restraining member 100. The outer diameter of the detent member 110 is larger than the inner diameter of the hollow portion 102.

  6 and 7 are cross-sectional views showing the shape of the distal end portion of the catheter 2 when the operation wire 40 is pulled. As shown in FIG. 6, when the manipulation wire 40 is pulled, the distal end portion of the catheter 2 is bent in the direction of the arrow X as the detent member 110 gradually moves toward the proximal side, that is, toward the restraining member 100. To do. In the middle of the movement of the detent member 110 toward the restraining member 100, the radius of curvature of the curved portion of the catheter 2 is substantially uniform, and the shape of the curved portion of the catheter 2 is approximated by an arc having a predetermined radius. be able to. Note that the radius of curvature gradually decreases as the detent member 110 moves toward the detent member 100. In other words, the radius of the arc that approximates the shape of the curved portion of the catheter 2 gradually decreases.

  Further, when the pulling operation of the operation wire 40 is advanced, as shown in FIG. 7, the movement preventing member 110 comes into contact with the restraining member 100, the movement of the movement preventing member 110 is restrained. The position is fixed by. In addition, a predetermined portion of the operation wire 40 on the distal side of the detent portion 110 is restrained in a region distal to the restraining member 100. When the operation wire 40 is further pulled in this state, the detent member 110 functions as an anchor, so that the degree of curvature increases at a portion proximal to the restraint member 100. In other words, the region of the catheter 2 proximal to the restraining member 100 is curved with a smaller radius of curvature than the region of the catheter 2 distal to the restraining member 100. That is, the curve shape of the catheter 2 has two stages.

  When the distance from the distal end of the catheter 2 to the restraining member 100 is 200 mm in a state where the catheter 2 is linear, the distance between the restraining member 100 and the detent member 110 is, for example, 30 mm.

  According to the catheter 2 of the first embodiment described above, the detent member 110 functions as an anchor that fixes a position at a predetermined distance from the distal end of the operation wire 40 when the operation wire 40 is pulled. Thus, the radius of curvature of the curved catheter 2 is different between the distal side and the proximal side of the restraining member 100, and the radius of curvature of the catheter 2 proximal to the restraining member 100 is the distal side of the restraining member 100. Smaller than the radius of curvature of 2. Thereby, the operativity of the catheter 2 improves and the catheter technique which penetrates the front-end | tip part of the catheter 2 to a more complicated path | route can be performed easily.

  In the present embodiment, the detent member 110 is integrally formed of the same material as the operation wire 40. In addition, the detent member 110 may be formed in a ring shape around the operation wire 40 using the same material as the operation wire 40 or a different material. A method of forming the movement stop member 110 as a separate member around the operation wire 40 is not particularly limited, and examples thereof include solder bonding, a crimping method by caulking, and fusion.

(Embodiment 2)
FIG. 8 is a cross-sectional view of the catheter 2 according to the second embodiment. About the catheter 2 of Embodiment 2, the same code | symbol is attached | subjected about the structure similar to Embodiment 1, and description is abbreviate | omitted suitably. The catheter 2 of the first embodiment has one set of the restraining member 100 and the detent member 110, but the catheter 2 of the second embodiment has two sets of the deterring member 100 and the detent member 110. In the present embodiment, one set of the restraining member 100 and the detent member 110 provided on the distal side of the catheter 2 are referred to as the deterring member 100a and the detent member 110a, and the other set of the deterring member 100 and the detent member. The member 110 is referred to as a restraining member 100b and a detent member 110b.

  In the present embodiment, the inner cylinder member 4a is composed of a member 4a1, a member 4a2, and a member 4a3 that become relatively less flexible in order from the distal end side. Moreover, the outer cylinder member 4b is comprised by the member 4b1, the member 4b2, the member 4b3, the member 4b4, and the member 4b5 which become relatively low in order from the distal end side.

  As shown in FIG. 8, the detent member 110a is provided between the anchor 41 and the restraining member 100a, and the detent member 110a is provided between the restraining member 100a and the restraining member 100b. In other words, the detent member 110a and detent member 110b are provided at predetermined positions of the operation wire 40 on the distal side of the deterrent member 100a and deterrent member 100b, respectively. When the catheter 2 is linear, the distance between the detent member 110a and the restraining member 100a is shorter than the distance between the detent member 110b and the restraining member 100b.

  In the present embodiment, when the operation wire 40 is pulled, first, the distal end portion of the catheter 2 is shown in FIG. 8 as the detent member 110a gradually moves toward the proximal side, that is, toward the detent member 100a. Curved in the direction of arrow Y. At this time, the curvature radius of the curved portion of the catheter 2 is substantially uniform. Further, when the pulling operation of the operation wire 40 is advanced, the detent member 110a comes into contact with the restraining member 100a, the movement of the detent member 110a is restrained, and the position of the detent member 110a is fixed by the restraining member 100a. In addition, a predetermined portion of the operation wire 40 on the distal side of the detent portion 110a is restrained in a region distal to the restraining member 100a. When the operation wire 40 is further pulled in this state, the detent member 110a functions as the first anchor, and therefore the degree of curvature increases at a portion closer to the restraint member 100a. In other words, the region of the catheter 2 proximal to the restraining member 100a is curved with a smaller radius of curvature than the region of the catheter 2 distal to the restraining member 100a. That is, the curve shape of the catheter 2 has two stages.

  Further, when the pulling operation of the operation wire 40 is advanced, the detent member 110b comes into contact with the restraining member 100b, the movement of the detent member 110b is restrained, and the position of the detent member 110b is fixed by the restraining member 100b. In addition, a predetermined portion of the operation wire 40 on the distal side of the detent portion 110b is restrained by a region distal to the restraining member 100b. If the operation wire 40 is further pulled in this state, the detent member 110b functions as a second anchor, and therefore the degree of curvature increases at a portion closer to the restraint member 100b. In other words, the region of the catheter 2 proximal to the restraining member 100b is curved with a smaller radius of curvature than the region of the catheter 2 distal to the restraining member 100b. That is, the curve shape of the catheter 2 has three stages.

  According to the catheter 2 of Embodiment 2 described above, when the operation wire 40 is pulled, the detent members 110a and 110b are anchors that fix a position at a predetermined distance from the distal end of the operation wire 40. Respectively, the curvature radius of the curved catheter 2 is different between the distal side and the proximal side with respect to each restraining member 100, and the curvature radius of the catheter 2 proximal to each restraining member 100 is different from each restraining member 100. It becomes smaller than the radius of curvature of the more distal catheter 2. Thereby, the operativity of the catheter 2 improves and the catheter technique which penetrates the front-end | tip part of the catheter 2 to a more complicated path | route can be performed easily.

  The present invention is not limited to the above-described embodiments, and various modifications such as design changes can be added based on the knowledge of those skilled in the art. The form can also be included in the scope of the present invention.

  For example, in the catheter 2 of Embodiment 2 described above, two sets of the restraining member 100 and the detent member 110 are provided, but three or more pairs of the restraining member 100 and the detent member 110 may be provided.

2 catheter, 4 tubular member, 10 tip electrode, 12 ring electrode, 20 first lumen, 22 second lumen, 24 third lumen, 26 fourth lumen, 40 operation wire, 100 restraining member, 110 Detent member

Claims (3)

A flexible tubular member having a plurality of lumens formed along the axial direction;
Of the plurality of lumens, an operation wire inserted through an operation lumen deviating from the central axis of the tubular member, and having one end connected to the vicinity of the distal end of the tubular member;
A restraining member provided between a distal end and a proximal end of the tubular member, wherein a hollow portion having an inner diameter smaller than an inner diameter of the operation lumen is provided so that the operation wire can be inserted;
A detent portion provided at a predetermined location of the operation wire located distal to the restraining member when the operation wire is linear, and having an outer diameter larger than an inner diameter of the hollow portion;
With
When the operation wire is pulled, a region distal to the movement stop portion of the operation wire is restrained by a region distal to the restraining member.   The curvature radius of the tubular member distal to the detent portion is larger than the radius of curvature of the tubular member proximal to the detent portion when the detent portion is restrained by the detent member. 2. The catheter according to 1. The restraining member is provided at a plurality of locations between a distal end and a proximal end of the tubular member;
The said movement wire is provided in the predetermined location of the said operation wire located in the distal side rather than the said said restraining member when the said operation wire is made linear form, respectively. The catheter according to the description.

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